NDC 68382-520-30 - sirolimus

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68382-520
Requested NDC: 68382-520-30
Package NDCs from labels: 68382-520-30, 68382-520-77, 68382-520-01, 68382-520-06, 68382-520-16, 68382-520-05, 68382-520-10
Manufacturer: American Health Packaging
Effective date: 2026-06-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
sirolimus - American Health Packaging	American Health Packaging	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL
sirolimus - REMEDYREPACK INC.	REMEDYREPACK INC.	2025-06-30	HUMAN PRESCRIPTION DRUG LABEL
sirolimus - Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-07-20	HUMAN PRESCRIPTION DRUG LABEL
Sirolimus - American Health Packaging	American Health Packaging	2019-05-16	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-520-01	sirolimus	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
68382-520-05	sirolimus	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
68382-520-06	sirolimus	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
68382-520-10	sirolimus	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16
68382-520-16	sirolimus	90 in 1 BOTTLE	TABLET, FILM COATED	90	16
68382-520-30	sirolimus	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	16
68382-520-77	sirolimus	10 in 1 CARTON	TABLET, FILM COATED	10	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-520	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 7 package rows	20230720_ec473170-47f1-4a5c-b4d9-ac36406ed241.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-520-01	EA - Each	68382-520	a47a1b24-e36b-4e22-bbe1-b79b63319de9	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIROLIMUS	ACTIVE INGREDIENT	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SIROLIMUS	ACTIVE MOIETY	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	5
SIROLIMUS	ACTIVE INGREDIENT	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
SIROLIMUS	ACTIVE MOIETY	W36ZG6FT64	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIROLIMUS TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 121 · 2,419 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
leader clearlax	POLYETHYLENE GLYCOL 3350	Cardinal Health 110, LLC. dba Leader	812c59b0-e7ce-4c7a-91ed-e74b7b1b84be	2026-09-22	Warnings	Exact identifier unii: G2M7P15E5P
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	L.N.K. International, Inc.	bbc11078-73f7-4d27-b0d3-4d4ae5dae240	2026-09-10	Warnings	Exact identifier unii: G2M7P15E5P
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier unii: FZ989GH94E
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	7ed915ec-7e99-4e0e-aca0-20718987a88c	2026-09-08	Warnings	Exact identifier unii: G2M7P15E5P
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: FZ989GH94E
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	fc3b6006-a75a-41b3-9f0b-a3152df1363f	2026-09-04	Warnings	Exact identifier unii: G2M7P15E5P
basic care clearlax	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	1ccb8604-34f6-4e1e-beed-eb81d6aa7aef	2026-09-03	Warnings	Exact identifier unii: G2M7P15E5P
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	006a9eca-400f-47f5-bee5-facf7034043e	2026-09-02	Warnings	Exact identifier unii: G2M7P15E5P
Kroger	POLYETHYLENE GLYCOL 3350	KROGER COMPANY	c56271ff-703a-40c4-840f-1962798c9e42	2026-09-02	Warnings	Exact identifier unii: G2M7P15E5P
gentle lax	POLYETHYLENE GLYCOL 3350	Kroger Company	0d820dcc-440a-4036-86e9-fdb30cac9573	2026-09-01	Warnings	Exact identifier unii: G2M7P15E5P
CLEARLAX	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	bd33463b-eb1a-41ed-92d1-f50d0923eb3b	2026-08-31	Warnings	Exact identifier unii: G2M7P15E5P
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	4d524ace-9de5-4f62-9263-7cd88a36b67c	2026-08-28	Warnings	Exact identifier unii: G2M7P15E5P
PEG3350	POLYETHYLENE GLYCOL 3350	Major Pharmaceuticals	161629f6-6193-4712-bba7-7d5b174a9338	2026-08-28	Warnings	Exact identifier unii: G2M7P15E5P
Calamine	FERRIC OXIDE RED	Your Military Exchanges	af95a66c-f063-4019-80c6-6f7dc4fee4d8	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
Mix-In Laxative Packets	POLYETHYLENE GLYCOL 3350	Wal-Mart Stores Inc	0347c934-1e85-4f8d-8d35-bb07f16810ad	2026-08-27	Warnings	Exact identifier unii: G2M7P15E5P
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.